九洲藥業(603456.SH):控股子公司九洲生物獲批成為磷酸西格列汀片上市許可持有人
格隆匯10月31日丨九洲藥業(603456.SH)公佈,公司控股子公司浙江九洲生物醫藥有限公司(簡稱“九洲生物”)於近日收到國家藥品監督管理局核准簽發的關於磷酸西格列汀片的《藥品補充申請批准通知書》。獲批准該品上市許可持有人由“山東朗諾製藥有限公司(地址:山東省德州市齊河縣晏北街道辦事處齊眾大道127號)”變更為“浙江九洲生物醫藥有限公司(浙江省杭州市經濟技術開發區下沙街道喬新路500號和科科技中心2幢一層103室)”。
磷酸西格列汀片主要用於治療2型糖尿病。磷酸西格列汀片由默沙東原研開發,是全球首個上市的DPP-4抑制劑,於2006年10月首次在美國上市,2009年9月批准進口。國內主要生產廠商有正大天晴藥業集團股份有限公司、通化東寶藥業股份有限公司等。公司暫未查詢到磷酸西格列汀片的公開銷售數據。根據國際糖尿病聯合會(IDF)公開數據顯示,2021年全球20-79歲成年糖尿病患者人數達到5.37億,其中我國患者數量超過1.4億,糖尿病患者數量多,降糖藥市場規模大。
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